Cleared Traditional

K080105 - ENDOTRACHEAL TUBE

K080105 is an FDA 510(k) clearance for ENDOTRACHEAL TUBE, manufactured by Chilecom Medical Devices Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K080105 · Chilecom Medical Devices Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
396d
Days
Class 2
Risk

K080105 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Chilecom Medical Devices Co., Ltd. (La Mirada, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K080105

510(k) Number K080105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date February 13, 2009
Days to Decision 396 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 140d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 204
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K080105.
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
K091591 · Flexicare Medical, Ltd. · Jun 2009
CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
K082038 · Clarus Medical, LLC · Apr 2009
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · Covidien · Apr 2009
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K080339 · Medsource International, LLC · Oct 2008
TRACHEOSCOPIC VENTILATION TUBE (TVT)
K082420 · Etview · Oct 2008
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · Mallinckrodt Medical · Oct 2008